Boyd Haley finally does the right thing, but is it for the wrong reasons?

As you may have heard, the strike is over. That doesn’t mean the crisis is over, nor does it necessarily mean that I will be staying with ScienceBlogs, but I view management’s response as a positive move that may be enough to keep me here. Now management needs to lose the Google ads for quackery, and then we have something to talk about. It seems that every time our benevolent overlords kill one set of quack ads, they disappear for a short while, only to reappear in a different guise. I think they understand that. At least I hope so.

In the meantime, I will speak no further of these issues, and there’s no reason not to return to business as usual, although I may try to keep things a bit shorter than usual in the beginning, mainly because either my allergy or a bad cold has turned my sinuses into inflamed balloons full of snot. That makes me particularly ornery, which is why I’m in the perfect mood to catch up on some developments that happened while Respectful Insolence was on its brief hiatus.

Remember the industrial chelator that disgraced crank chemistry professor Boyd Haley tried to market as a dietary supplement, “reasoning” that because it has a benzoate chemical group, which, as he points out, is found in cranberries, and two cystamine groups, which are found in meats it’s made up of two “natural food” elements? Yes, I’m talking about OSR#1, which the FDA tried to shut down. Boyd Haley’s argument was, of course, risible in the extreme, so much so that either he’s forgotten all the knowledge of chemistry that he learned in his career or he was lying through his teeth with utter contempt for his audience. Just yesterday, there was a Tweet from Boyd Haley:

Registered Medical Professionals: Please review your email for an important message about the future availability of OSR#1Â®. www.OSR1.com

Then a little bird forwarded this to me:

On 18 June 2010, the FDA wrote to CTI Science questioning whether OSR#1Â® fit within the agency’s definition of a dietary supplement, indicating that instead it appeared to be a drug. Although we believe the product meets the legal definition of a “dietary supplement,” we have decided not to contest this point but to work with the agency. While achieving formal drug approval is lengthy and costly, CTI Science will in the course of it prove to FDA’s satisfaction the safety and efficacy of OSR#1Â® and ultimately be able to offer OSR#1Â® to the public with FDA-authorized therapeutic claims.

As a result of this decision, CTI Science has voluntarily agreed to remove OSR#1Â® from the market effective Thursday, 29 July 2010. The product will not be available for sale after that date until new drug approval has been obtained. Please continue to access our website, www.ctiscience.com , for updates on OSR#1Â® in the future.

On a personal note, I have met most of the medical professionals we deal with, and your passion and dedication to excellence are rarely seen these days. It has been an honor to work with you, and I am deeply appreciative of the support you have shown in the past. Please accept my best wishes for your continued success. I look forward to working with you in the future again with OSR#1Â®.

Boyd E. Haley, PhD

President
CTI Science-Color-EM
CTI Science, Inc.

My question is this: Why don’t Haley and CTI Science simply shut down production and sales now? Why sell OSR#1 for another week? My guess is that the answer is that Haley wants to milk his cash cow for one more week. All the quacks who “prescribe” or recommend OSR#1 to their clients will rush out to buy a boatload of the stuff before Haley cuts off the supply. It’s pure profit, because the stuff costs only $0.25 per gram to synthesize. I don’t know what Haley sells OSR#1 for wholesale, but Kathleen Seidel points out that certain retailers sell it for $60 to $105 for 30-100 mg capsules of OSR#1. That’s right: $20 to $35 a gram–seriously righteous bucks, a markup of up to 14,000%. Given that the Univesity of Kentucky bore the costs of development, and the packaging and filler can’t cost all that much. One can only imagine that shortages in the wake of Haley’s shutting down production will boost that profit potential even more. One can even imagine that, given that the chemical formula isn’t too complex, others might step in and synthesize OSR#1 the way Jim Tassano synthesized DCA.

You know, if Haley had simply shut down sales immediately, I might have grudgingly lauded him for finally doing the right thing. OSR#1 is clearly not a dietary supplement. It does not derive from any natural products, and it is synthesized in a laboratory. Moreover, it’s being marketed as an “antioxidant” for the treatment of autism. It makes definite drug claims, and it’s being used as a drug. It’s been associated with adverse events being reported on chelation therapy boards that represent the dark underbelly of the “autism biomed” movement. Before any more OSR#1 is ingested by even a single autistic child, OSR#1 needs to undergo the same testing and clinical trials that any new drug candidate. That is the single standard proponents of science-based medicine advocate.

57 Comments

“reasoning” that because it has a benzoate chemical group, which, as he points out, is found in cranberries, and two cystamine groups, which are found in meats it’s made up of two “natural food” elements?

The carbon atom is found in the natural and safe molecule DNA. The nitrogen atom is found in the natural and safe molecule DNA. Hence, if you add one carbon atom to one nitrogen atom, the result must be perfectly safe, right?

…

What, you’re telling me that cyanide is poisonous? Nonsense! It’s found in all natural apple seeds! It has to be healthy!!

For that matter, the amino acids cysteine and glycine are found in insulin – a vital hormone required for normal metabolism – and in alpha-conotoxin – a deadly snail toxin. The fact that the same 22 amino acids are used to make essential cellular components and deadly poisons gives the lie to Professor Haley’s glib “explanation”.

I suspect, too, that the FDA is not going to be any more convinced than I am. In fact, I think that Professor Haley may well come to wish he had shut down OSR sales immediately rather than trying to clear out remaining inventory through this “Fire Sale” notice.

He’s making it look like he doesn’t take the FDA seriously, and I don’t think they’ll take that very well.

Mmmmmmmmm. Chelorex. One Caplet Contains 12 Ingredients To Remove 16 Heavy Metals That Negatively Impact Your Health. Sixteen heavy metals!?!? Well, why didn’t you say so in the first place? With ads like that popping up here, I guess they really don’t really want you to stay.

BDTH2 [a.k.a. OSR #1] is also effective in the aqueous precipitation of other soft, divalent metals, such as copper, cadmium, lead, and the main group elements, arsenic and selenium.

Copper is a biologically essential metal. And calcium is a divalent metal, and is “soft”, if the “soft” in the quote above refers to physical hardness. Calcium is essential in the process of muscle contraction.

And since OSR has an affinity for cadmium, from Wikipedia’s article on cadmium:

Cadmium is a chemical element with the symbol Cd and atomic number 48. The soft, bluish-white metal is chemically similar to the two other metals in group 12, zinc and mercury. Similar to zinc it prefers oxidation state +2 in most of its compounds and similar to mercury it shows a low melting point compared to transition metals.

Given that it has affinity for cadmium and mercury, it sounds like it might also have affinity for zinc, another biologically essential metal.

Of course, a chelator having affinity for biologically essential metals doesn’t (necessarily) mean it should never be used, just that it should only be used under supervision by a qualified medical doctor, rather than be sold as a dietary supplement.

Woot! Orac’s back, and with great good news to boot! Strikes me that Haley might want to have a little caution with the hubris there – I mean, “CTI Science will in the course of it prove to FDA’s satisfaction the safety and efficacy of OSR#1Â® and ultimately be able to offer OSR#1Â® to the public with FDA-authorized therapeutic claims.” Seriously? Ah, well, I suppose he’s not worried about egg on his face when his little “supplement” fails miserably – he’ll just claim Big Pharma persecution, after all.

And, Orac, dear – from my “inflamed balloons full of snot” to yours, I feel for ya, buddy. Why, just today, I was thrilled by the milestone of having made it through a whole hour without needing to blow my nose. Summer colds (and/or summer allergies) suck mightily.

Here are the things I’m worried about with his seeking of FDA approval:

* Institutions that will conduct the studies (Thoughtful House? Wherever the Geiers do their crap?)
* The IRBs that review the protocols. Will it be a hodge-podge of conflict cronies like the Geiers tried to get away with?
* Ultimately, the safety of the study subjects. Will they be adequately protected? With something like a chelator, I would expect a DSMB to be in place. And like the IRB, who will be on the DSMB?

I wonder if he also realizes that he’ll need to register and post results on clinicaltrials.gov. In any event, if his research methods are in any way similar to his marketing, I really worry about the well-being of potential subjects. And, given the likely population of subjects (OSR#1 fans and their autistic children), I would really like to see a subject advocate in place, too, to counter what may be hasty consent by the parents.

“In fact, I think that Professor Haley may well come to wish he had shut down OSR sales immediately rather than trying to clear out remaining inventory through this “Fire Sale” notice.”

He seems to be saying, “Well, they say it’s illegal to sell this stuff, and in the long run it would cost too much to fight them, so let’s just go ahead and sell it for another week, because in the short run, it would cost them too much to raid anyone over the sale of a few grams.”

I don’t believe he will go through the expense and likely ultimate failure of winning drug approval. I’m betting he will offshore it under another name and brand. Probably several names and brands, making the FDA work that much harder and take that much longer to shut down each of those operations if they can.

With the amount of profit Orac estimates, the fanatical demand, and the buyer’s disregard for consequences or placing blame on him, Haley would be a fool not to find a way to bring this crap back. He would very likely be able to raise the price as a result of the increased offshoring costs. I bet six months at the outside.

The thing that, while I shouldn’t be surprised, amazes the hell out of me is the sheer hypocrisy of his supporters. If any pharmaceutical company tried to do the exact same thing he was doing, many of them would be all over the company, crying foul and so on.

@ DLC: Mr. Poe, while the great nullifier-of-all-reason still hawks supplements at his woo-teria (see website), he has *additional ways* of helping you: most recently( and hilariously),he gave a lecture (which could have been attended live in NYC or by internet @$20) on how to have a “perfect relationship” based on his own personal theory of personality ( films and books available)…. I was thinking about attending along with friends ( one does marriage counselling- both have fabulous Irish accents) so we could toss some loaded questions however that would mean $60 in his woo-sustained coffers.

I think we’re too optimistic here, what gets me is the with FDA-authorized therapeutic claims statement. They only need to get one therapeutic claim approved, at one “safe dosage”. Oh well, now it’s a safe chelator for acute heavy metal intoxication at 10 mg for 7 days. They can sell it in 1000 pill bottles, and its not their fault that people are using it to treat autism by feeding their kids 100 mg a day long term. That’s just “off-label” use of an FDA approved medication.

Here’s basically how drug regulation works. If you have a product and you want to be able to market it to cure, treat, mitigate or diagnose a disease or condition, you need to run Phase I-III clinical trials and apply for marketing approval to the FDA. Depending on the safety profile/existence of similar products, you may be able to get expedited review or exemption from some of the regulations. Once you get approval, you can market the product for the claims for which you gained approval. If you want to add an indication or significantly change the approved populations, dosage, administration or formulation, and market the new indication, etc., you need to go through FDA again.

Once a product is approved by the FDA, you can only actively market (which includes anyone from your company/organization promoting its use) for the approved indications/populations/dosage/form. Physicians, on the other hand, are under no such obligation to the FDA and can use the product however they see fit, though they should have reasonable scientific justification for using a product off-label (e.g., published journal articles supporting the off-label use). FDA does not regulate the “practice of medicine”.

So, what Mu says is a possibility. Haley does the studies to gain approval for it as a chelating agent for heavy metal toxicity and markets it as such, all the while his patron quacks physicians hawk it to their patients as the “dietary supplement” or “autism treatment”. Unless he specifically tests for and submits an application for approval of an autism treatment claim to the FDA, he would not be able to actively market those claims (which, remember, would include him or anyone from his company talking up its use as an autism treatment in an attempt to increase sales). There’s a fine line, too, between sales and informational presentations at conferences. Kind of a hazy area in the regulations.

All things being equal, I’m glad that products like Chelorex and such are advertised here, just like I’m glad when creationists advertise on Pharyngula. Each dollar they spend on advertising here is a dollar they won’t spend on advertising in a place that might actually generate sales.

With regards to the whole OSR#1 debacle, they’re doing the equivalent of ‘Buy your cigarettes before the price jumps’. I also agree with Rogue Medic, and I’m guessing that Boyd Haley’ll be back eventually – probably with a different company – with OSR#2.

If he tries this, does the FDA have the legal ability to tie the companies together? How much of the company is Boyd Haley?

The FDA can only take action based on the products sold/claims made. He could set up under a different guise, but FDA would basically have to start from scratch in going after the new entity. At least, that’s the impression that I have. The FTC on the other hand might be better able to tie the different entities together and take legal action against Haley, to bar him selling or making fraudulent claims. We’d really need to see what happens. Other than what’s already taken place, there’s not a whole lot that can be done about future incarnations.

It was obvious from the content of the warning letter that Boyd Haley would have no choice but to stop shipping OSR#1. Failing to do so would have put Haley on a one-way track leading inexorably to crippling fines and some combination of

(a) a consent decree spelling the end of the company,

(b) having his doors chained shut, and

(c) time in prison.

That’s the way these things work. People do the right thing every day to avoid going to jail, but they don’t deserve special credit for it.

I don’t understand why ads are considered a necessary evil. Nobody in their right mind sees them or follows them, and it makes no sense at all that marketing idiots fight so hard over their silly virtual billboards.

Meanwhile hosting costs are so low that you can have an ad-free site for less than most yuppies spend on coffee every month.

If I was blogging and wanted to preserve my integrity and credibility, I’d pony up the $200/year or so that hosting costs (and that’s with a pretty big server/bandwith package) and not have any ads on my site. Keeping ranum.com ad-free and self-hosted for the last 10 years has cost me, basically, nothing, because it’s probably landed me a couple of contracts. The whole advertising mania and model is stupidity that – hopefully – everyone will eventually wake up and forget about.

As Richard Feynman once said – if everyone simply didn’t buy anything that they saw advertised, in 3 months none of us would ever see another ad.

Nobody in their right mind sees them or follows them, and it makes no sense at all that marketing idiots fight so hard over their silly virtual billboards.

You’re overgeneralizing from yourself. Perhaps YOU don’t follow ads, but many other people DO. They’ve been found to be quite cost-effective, actually – far more so than most other forms of advertising.

Question: for orally taken chelators, will they bind to dietary metals while in the digestive system, before being absorbed by the intestines? For example, if you ate some OSR #1 with a glass of milk, would the OSR bind to the dietary calcium:

1) reducing the amount of dietary calcium available to the body.

2) reducing the amount of unbound OSR available to chelate heavy metals. (Or would OSR already bound to calcium release the calcium to bind to heavy metals?)

@Todd W:

The thing that, while I shouldn’t be surprised, amazes the hell out of me is the sheer hypocrisy of his supporters. If any pharmaceutical company tried to do the exact same thing he was doing, many of them would be all over the company, crying foul and so on.

Someone else (several someone elses?) noted that, for these types of people, what matters is the (perceived) motivation of those manufacturing/selling the drug. They perceive Haley as being motivated by helping autistic children, so he doesn’t need to prove to the world that OSR is safe. If his motive is to help autistic children, then he can simply be trusted to have done everything necessary to ensure that OSR is perfectly safe.

… Or something like that.

@Todd W.:

The FDA can only take action based on the products sold/claims made. He could set up under a different guise, but FDA would basically have to start from scratch in going after the new entity. At least, that’s the impression that I have.

Can’t the FDA take any action based on the active ingredient being identical?

“…my allergy or a bad cold has turned my sinuses into inflamed balloons full of snot. That makes me particularly ornery”
When facing a night of suffocation via inflammed sinuses, I take the Pliny the Elder remedy…a clove of fresh garlic with cold water. If eating a clove isn’t completely effective, I cut up one or two others and apply them with medical tape to the sinuses surrounding my eyes. Yes, it can burn the skin, but the effect is almost always effective in unplugging the sinuses.

“…my allergy or a bad cold has turned my sinuses into inflamed balloons full of snot. That makes me particularly ornery”
When facing a night of suffocation via inflammed sinuses, I take the Pliny the Elder remedy…a clove of fresh garlic with cold water. If eating a clove isn’t completely effective, I cut up one or two others and apply them with medical tape to the sinuses surrounding my eyes. Yes, it can burn the skin, but the effect is almost always effective in unplugging the sinuses.

They only need to get one therapeutic claim approved, at one “safe dosage”. Oh well, now it’s a safe chelator for acute heavy metal intoxication at 10 mg for 7 days. They can sell it in 1000 pill bottles, and its not their fault that people are using it to treat autism by feeding their kids 100 mg a day long term. That’s just “off-label” use of an FDA approved medication.

Didn’t Haley start calling it a “dietary supplement”, and stop referring to it as a chelator for heavy metals (indeed, refusing to refer to it as a chelator) to avoid having to do any testing of it as a heavy metal chelator? If he did do the testing to get it approved for that, wouldn’t he just drop the dietary supplement pretense?

Personally I take very hot lemonade, sweetened with maple syrup & dosed with as much hot sauce as I can handle. The hot sauce is to make my nose run as much as possible while sipping. It seems to slow down the post-beverage snot production for a while.

Now, back to the topic:

It’s been more than 24 hours since the Boyd Haley story broke via twitter & the message above.

Age of Autism hasn’t posted or tweeted a word about it…they sure were quick to post Haley’s self-serving op-ed. “OSR: Dietary Supplement Safe for Right Use”

Someone else (several someone elses?) noted that, for these types of people, what matters is the (perceived) motivation of those manufacturing/selling the drug. They perceive Haley as being motivated by helping autistic children, so he doesn’t need to prove to the world that OSR is safe. If his motive is to help autistic children, then he can simply be trusted to have done everything necessary to ensure that OSR is perfectly safe.

… Or something like that.

Is there a name for this sort of thinking? The pattern shows up so often in altmedland that’d it be nice to have a handy label (and a WP page to link to).

MC wrote Didn’t Haley start calling it a “dietary supplement”, and stop referring to it as a chelator for heavy metals (indeed, refusing to refer to it as a chelator) to avoid having to do any testing of it as a heavy metal chelator?
Yes, he did that to get around having to do any testing at all. Now that he’s forced into testing he needs to regroup. Part of the FDA approval is showing efficacy, and he can do that heavy metal chelation much easier than for autism. So, if he can show it works as a chelator, and it has a safe dosage, and he can make some form of claim it’s better/cheaper/safer than the existing products, he can get it approved, if only for a niche application. But that’s all it takes to get it on the market, and then people like the Geiers or Thoughtful House can legally approve years of study to test for efficacy with autism, giving semi-respectability to the DAN doctors who suggest it off-label (it’s in clinical trials for that after all).

Now that he’s forced into testing he needs to regroup. Part of the FDA approval is showing efficacy, and he can do that heavy metal chelation much easier than for autism. So, if he can show it works as a chelator, and it has a safe dosage, and he can make some form of claim it’s better/cheaper/safer than the existing products,

But at that point it becomes just another medical-grade heavy metal chelator, which DAN doctors and the like are already using on autistic children. My point being that no one would be treating it as a mere dietary supplement like they are now.

We have used it with amazing results. Our kids’ glutathione levels have normalized and we can tell when we skip using the product. Boyd Haley is not only a man of tremendous compassion, but generous. He did not charge us anything for it. Many people invested a lot of money in his research which is not free. People have been on a witch hunt. It is unfortunate we cannot afford to buy more of the product. We are almost out. He gave us a year’s supply for all of our children who were in need. We are very, very grateful for his generosity, his hard work and dedication to children.

We have used it with amazing results. Our kids’ glutathione levels have normalized and we can tell when we skip using the product. Boyd Haley is not only a man of tremendous compassion, but generous. He did not charge us anything for it.

Considering that you probably had your tests done by a lab such as Doctors Data, Genova or Great Plains and ‘interpreted’ by a DAN!, it is no surprise that you believe OSR produced positive results. So tell me, where are the treatment groups with matched control groups that Haley used to determine the safety and efficacy of his product?

Street drug dealers also give away free samples to those they believe will become regular buyers and also attract more. You seem more impressed with his ‘generosity’ than the fact that you are giving your children an industrial chelator created for cleaning mining sludge.

We have used it with amazing results. Our kids’ glutathione levels have normalized and we can tell when we skip using the product.

OSR is a chelator, and is marketed as an anti-oxidant. As a chelator it would have no effect on glutathione, since glutathione contains no metal atoms. As an anti-oxidant, well, glutathione is also an anti-oxidant. (Or maybe you mean it’s normalized the ratio of reduced glutathione to oxidized glutathione?)

Anyways, if your kid needs an anti-oxidant, use one that isn’t a chelator. Seriously.

@Matthew Cline
The softness of metals referred to is according to the Hard Soft Acid Base theory (http://en.wikipedia.org/wiki/HSAB_theory). Sulphur is a soft electron-pair-donor (in this theory, electron-pair-donors are called bases), so it will bond to soft electron-pair-acceptors (acids) such as mercury and cadmium. Calcium is a hard acceptor, so it will prefer to bond to hard donors, typically oxygen-containing (which is why calcium oxalate precipitates). Zinc is borderline, and will bond to both hard and soft donors, so the OSR#1 will bond to it, but not as efficient as it does to mercury.

But, in general, chelators do nasty things amount of minerals available to the body, and should not be used without a doctor supervising the process, and not without a very good reason.

Didn’t Haley start calling it a “dietary supplement”, and stop referring to it as a chelator for heavy metals (indeed, refusing to refer to it as a chelator) to avoid having to do any testing of it as a heavy metal chelator? If he did do the testing to get it approved for that, wouldn’t he just drop the dietary supplement pretense?

The Chelorex that was being advertised here had Dietary Supplement written on the label.

I don’t know if they had obtained any approval as a medication, but this gives the appearance of calling it both a chelator and a dietary supplement. I think they also brag that their chelation dietary supplement crosses the blood/brain barrier, so that it is able to suck out of the brain all of the chemicalsmineralsmetalsheavy metals things that the DAN doctors say are bad.

As if they would know. As if their testing is anything more than a part of their sales pitch.

I keep waiting to see somebody advertising something like “concentrated rhubarb pills” to treat autism (since, technically, it contains a chelator, oxalic acid). At least in that case, it would actually be something generally recognized as both safe and, y’know, *food*.

The person who wrote that article is obviously a very biased idiot being paid by someone who simply doesn’t want that wonderfull product on the market !! Folks don’t listen to all that bull he wrote on CRS1 !!!

andrew, the likely drive-by troll,
No one is going to take you seriously if you do not provide some evidence of your claims. Do you have some evidence to indicate the article is wrong in some way? What do you disagree with any why?

In fact if we look at the article and your posting, it seems you are more likely to be paid by someone, you pop onto a blog post about a product, you post something saying it is wonderful and should be on the market. But I guess you most likely do not want anyone to apply your standards to yourself.

Sorry, don’t feel sorry for you about your sinuses. If only you trusted alternative meds more, you might not be suffering so much. By the way, chlorella is used for toxic waste clean up and is safe to ingest; so quit the baloney of using word descriptions/associations to conjure up all sorts of horrible images in people’s minds. Just stick with objective facts, name your sources, and cite the studies. There are way too many cases of solid science being silenced because it was not “convenient” for some entity at the time. It’s to the point where so many people feel there is no science we can trust, no source free from contamination/self- or special-interest. By the way, did you speak directly with Boyd Haley? Did you look over everything he submitted to the FDA? If you did due diligence as a scientist or reporter, I would hope so, and then have you report that here. Also, I could accept taking Haley to task over profiting excessively from the product if you did the same for the rest of the pharmaceutical industry. Sorry, but your biases seem to be showing. I would so like to find a bias-free source.

By the way, chlorella is used for toxic waste clean up and is safe to ingest; so quit the baloney of using word descriptions/associations to conjure up all sorts of horrible images in people’s minds.

What, because one product used for toxic waste cleanup is theoretically edible (I’m not a big fan of eating algae, personally, though it could be an important element of future spaceflight), all of them must be?

The point of OSR 1 being tested only as an industrial chelator is not that industrial stuff is fundamentally bad. It’s that industrial standards are radically different than food or drug standards (industrial salt isn’t something you’d want to put on your food unless you like playing roulette with any contaminants that may be in it) and that having proven it will work as a chelator in the soil is a very different thing from proving it’ll work as a chelator in the human body. (And it has absolutely zip doodle to do with proving it to be safe to ingest at the recommended dose, which Haley has not done at all. Hell, he really hasn’t even established a recommended dose.)

Also, I could accept taking Haley to task over profiting excessively from the product if you did the same for the rest of the pharmaceutical industry.

You must be new here. Orac has written on that topic before.

Personally, my main beef is that so many people suffer under the delusion that fraud and greed are somehow peculiar to companies which make FDA-approved products, and that non-FDA approved products must be free of this sort of thing. In fact, all drug manufacturers (no matter what they call themselves) are prone to fraud, greed, and waste, which is why I don’t trust any of them. At least with the FDA-approved stuff, at least a minimum of due diligence has been performed. Can’t say the same for OSR 1.

I also find it interesting that you are willing to accept complaining about “profiting excessively” but evidently have a problem with complaining that the product has never been properly tested as a drug or food additive, and really has only been tested in industrial applications.

“It’s to the point where so many people feel there is no science we can trust, no source free from contamination/self- or special-interest.”

For example, a scientist who says that a certain industrial chelator is safe for human use without having actually done the safety studies and who – it just so happens – is selling this industrial chelator for human use? Is that the sort of “contamination, self- or special-interest” she had in mind?

“…I could accept taking Haley to task over profiting excessively from the product if you did the same for the rest of the pharmaceutical industry.”

I don’t think that Orac was taking Dr. Haley to task for excessive profits so much as for selling a chemical for human consumption that hasn’t been shown to be either safe or effective in humans.

I’m pretty sure that if someone in the real pharmaceutical industry (as opposed to the “supplement industry” that Dr. Haley insists he is in) sold something that hadn’t been shown to be safe and effective – at least to the minimal standards required by the FDA – they would be looking at massive fines and possible jail time. I think that Orac’s opprobrium would be the least of their worries, but I’m sure they’d get that, as well.

Drugs that are approved are fast tracked through the FDA approval process, only to be met with massive law suits for death and permanent harm. The FDA shut down Professor Haley, not because OSR did not work, but because there is a policy/rule on the books that states that the FDA holds all rights to any product that is distributed as a cure for anything. Professor Haley holds the patent on OSR…OOPS!

Drugs that are approved are fast tracked through the FDA approval process, only to be met with massive law suits for death and permanent harm. The FDA shut down Professor Haley, not because OSR did not work, but because there is a policy on the books that states that the FDA holds all rights to any product that is distributed as a cure for anything. Professor Haley holds the patent on OSR…OOPS!